PRIME: PrEP Intervention for people who Inject MEthamphetamine

PRIME：针对注射甲基苯丙胺患者的 PrEP 干预

基本信息

批准号：
10223260
负责人：
PHILLIP O COFFIN
金额：
$ 82.89万
依托单位：
PUBLIC HEALTH FOUNDATION ENTERPRISES
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-08-01 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10223260
关键词：
AIDS prevention Address Adherence Adult Affect Attention Blood Bupropion Car Phone Centers for Disease Control and Prevention (U.S.)Client satisfaction Clinical Trials Contracts Counseling Data Disease Disease Outbreaks Dose Effectiveness Enrollment Ensure Epidemic Financial compensation Future HIV HIV Infections HIV Seronegativity HIV risk Habits Health Incentives Infection Injecting drug user Injections Intervention Interview Life Style Location Measures Methamphetamine Modeling Oral Outcome Measure Participant Pattern Persons Pharmacology Population Questionnaires Randomized Randomized Controlled Trials Records Reporting Risk Risk Behaviors San Francisco Sexual Transmission Spottings Standardization Surveys Syringes System Telephone Tenofovir Testing Time United States Viral Visit adherence rate aggressive therapy arm behavior change condoms contingency management emtricitabine follow-up high risk high risk population implementation study improved injection drug use interest medication compliance methamphetamine use mobile application opioid epidemic pre-exposure prophylaxis prevent primary outcome programs recruit sexual HIV transmission sexual risk behavior time use tool transmission process trial comparing two-arm trial usability willingness

项目摘要

Project Summary/Abstract Notwithstanding a substantial effort of “getting to zero”, new HIV infections among people who inject drugs are increasing. Methamphetamine is a primary driver of that increase, as methamphetamine use has been extensively demonstrated to increase both sexual and injection-related HIV transmission. Methamphetamine use is also associated with poor medication adherence, such that people with HIV who use methamphetamine are less likely to be virally suppressed. The most powerful tool for prevention of HIV available today, in addition to aggressive treatment of people living with HIV to ensure viral suppression, is pre-exposure prophylaxis (PrEP) with emtricitabine plus a tenofovir product (e.g. FTC/TAF). PrEP has been extensively demonstrated to reduce HIV infection when taken in sufficient amounts, generally defined as ≥4 doses per week. The Centers for Disease Control and other health agencies recommend PrEP for people who inject drugs, yet there has been precious little attention to this population in PrEP clinical trials, implementation studies, and demonstration projects. Two major reasons for this lack of attention are (1) that syringe access programs, where available, are powerful tools to lower HIV transmission by injection, and (2) that people who inject drugs – and in particular people who use methamphetamine – are likely to struggle with medication adherence. In the context of expanding methamphetamine use – as the next wave of the opioid crisis – and a national effort to eliminate HIV transmission, syringe access programs are unlikely to be sufficient to prevent the remaining infections that occur. In this study, “PrEP Intervention for people who Inject Methamphetamine” (PRIME), we propose to address the second concern by testing a combined adherence intervention. PRIME is a two-arm trial comparing standardized counseling to video directly-observed treatment with real-time contingency management (VDOT-CM) for adherence to once-daily emtricitabine/tenofovir alafenamide (FTC/TAF) PrEP among people who inject methamphetamine. We will randomize 140 adults who inject methamphetamine, are HIV-negative, and have recently engaged in HIV risk behaviors to VDOT-CM or counseling alone for 24 weeks. Both groups will receive PrEP and counseling to support PrEP adherence; the intervention condition will also receive a mobile phone app that video records daily PrEP use and a nominal contingency management incentive to complete the observed PrEP dosing. We will compare adherence to PrEP in both arms by testing dried blood spots for tenofovir disphosphate (TFV-DP) levels of ≥ 950 fmol/punch, corresponding to ≥4 doses per week. We will assess acceptability of PrEP in this population through qualitative interviews and survey items. Finally, we will compare injection and sexual risk behaviors prior to PrEP to those while on PrEP, to evaluate for risk compensation. Study results will provide critical data for intensive adherence support for PrEP among people who inject methamphetamine, a very high risk population for HIV transmission.

项目概要/摘要尽管为“实现零”做出了巨大努力，但注射吸毒者中的新艾滋病毒感染人数仍在增加甲基苯丙胺的增加是这一增长的主要驱动因素，因为甲基苯丙胺的使用一直在增加。通常被证明会增加性行为和注射相关的艾滋病毒传播。使用甲基苯丙胺还与药物依从性差有关，例如使用甲基苯丙胺的艾滋病毒感染者此外，它不太可能被病毒抑制，这是当今预防艾滋病毒最有力的工具。暴露前预防是对艾滋病毒感染者进行积极治疗以确保病毒抑制的方法恩曲他滨加替诺福韦产品（例如 FTC/TAF）的 PrEP（PrEP）通常被证明可以有效。服用足够量（通常定义为每周 ≥ 4 剂）可减少 HIV 感染。疾病控制和其他卫生机构建议注射吸毒者进行 PrEP，但目前还没有 PrEP 临床试验、实施研究和研究中对这一人群的关注很少缺乏关注的两个主要原因是（1）注射器获取计划，如果有的话，是降低艾滋病毒注射传播的有力工具，并且 (2) 注射吸毒者 – 特别是使用甲基苯丙胺的人 – 可能会在药物依从性方面遇到困难。作为阿片类药物危机的下一波浪潮，甲基苯丙胺使用范围不断扩大，以及国家努力消除艾滋病毒传播，注射器获取计划不太可能足以防止剩余的艾滋病毒传播在这项研究“注射甲基苯丙胺的人的 PrEP 干预”（PRIME）中，我们建议通过测试联合依从性干预来解决第二个问题。比较标准化咨询与实时应急视频直接观察治疗的试验坚持每日一次恩曲他滨/替诺福韦艾拉酚胺 (FTC/TAF) PrEP 管理 (VDOT-CM) 我们将随机抽取 140 名注射甲基苯丙胺的成年人。 HIV 呈阴性，并且最近曾进行过 VDOT-CM 的 HIV 危险行为或单独咨询 24 周。两组都将接受 PrEP 和咨询，以支持 PrEP 依从性；收到一个手机应用程序，可以视频记录日常 PrEP 使用情况和名义上的应急管理我们将通过测试比较双臂对 PrEP 的依从性。干血斑中二磷酸替诺福韦 (TFV-DP) 水平≥ 950 fmol/孔，相当于 ≥ 4 剂每周，我们将通过定性访谈和调查来评估该人群对 PrEP 的接受程度。最后，我们将比较 PrEP 之前和 PrEP 期间的注射和性风险行为。评估风险补偿，研究结果将为 PrEP 的强化依从性支持提供关键数据。注射甲基苯丙胺的人群是艾滋病毒传播的高危人群。